BridgeMD
New treatment option for Primary IgA-nephropathy
Official title Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy
ClinicalTrials.gov ID: NCT07074951
What this study is testing
What is Immunosuppressive treatment?
Immunosuppressive treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary iga-nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Primary IgA-nephropathy (IgAN) patients with:
- DP \>1 g with haematuria (\>5 RBC/HPF)
- DP \ 11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the...
You likely can't join if
- Age \ 75 years;
- eGFR ≤20 ml/min/1.73m2
- Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \<1.0 g
- Contraindications to IST or TE
- Patients with any co-existing kidney disease
- Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
See the full eligibility criteria
- Primary IgA-nephropathy (IgAN) patients with:
- DP \>1 g with haematuria (\>5 RBC/HPF)
- DP \ 11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary...
- Age \ 75 years;
- eGFR ≤20 ml/min/1.73m2
- Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \<1.0 g
- Contraindications to IST or TE
- Patients with any co-existing kidney disease
- Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
- Patients with diabetes mellitus
- Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can...
- Incomplete empiric IST administered prior to kidney biopsy
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.